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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Polymeric
510(k) Number K090271
Device Name HYDROCOAT MESH
Applicant
Promethean Surgical Devices, Inc.
111 Roberts St.
Suite, G2
East Harford,  CT  06108
Applicant Contact KENNETH K KLEINHENZ
Correspondent
Promethean Surgical Devices, Inc.
111 Roberts St.
Suite, G2
East Harford,  CT  06108
Correspondent Contact KENNETH K KLEINHENZ
Regulation Number878.3300
Classification Product Code
FTL  
Date Received02/04/2009
Decision Date 01/14/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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